Involvement of Transverso-sacral- Neo- Articulations or of Transverso-iliac Articulations in Chronic Lumbago

Nantes University Hospital (NUH)

Status and phase: Terminated; Phase 4

Conditions: Subjects Suffering of Lateralized Lumbago on Side of the Malformation (Neo-articulation)

Treatments: Drug: corticoid (altim® 1.5 ml); Drug: physiological solution (1.5 ml)

Study type: Interventional

Funder types: Other

Identifiers

NCT01206699

10/3-N

Details and patient eligibility

About

The specific aim of this study is to determine whether, when treated with corticoid infiltration, certain chronic lumbagos could be explained by the presence of a neo-articulation.The primary criteria is to determine the difference between the mean pain during the latest 24 hours preceding the infiltration and the mean pain preceding the visit S4 (visit 4 weeks after the infiltration)

Enrollment: 16 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adult with age equal or above to 18.
• Subject affiliated to French health insurance (Sécurité Sociale)
• Lateralized lumbago on side of the neo-articulation evolving since more than 3 months
• Mechanical pain, lumbar low level or gluteal without sciatic irradiation (pain above the knee)
• Mean pain during the latest 24 hours above 4 on an analogic visual scale (from 0 to 10)- Pain induced by palpation in regards to the neo-articulation
• Pain not relieved by medical treatment with non steroids anti- inflammatory drugs or antalgics
• No clinical proof for a discal origin : inducing factor, impulsiveness, spinal syndrome, true Lasègue
• transverse-sacral abnormality of IIb, IIIa, IIIc or IV type with neo-articulation lateralized on side of pain
• Informed consent form signed

Exclusion criteria

• Age below 18
• Clinical arguments in favour of a discal origin
• Pregnant women or women that could become pregnant the day of the infiltration
• Diabetic patient
• Patient unable to understand the protocol
• No autonomy for coming to the hospital (no budget allocated for patient transportation)
• Hypersensitivity to local anesthetics with "liaison amide"
• Hypersensitivity to one of the components
• Porphyria- Local or generalized infection, suspiscion of infection
• Severe troubles of coagulation, anti-coagulant treatment taken
• Bilateral lumbago with bilateral neo-articulation

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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16 participants in 2 patient groups, including a placebo group

corticoid

Experimental group

Description:

Active arm : anesthetic bloc (1 ml of lidocaïne 1%) immediately followed with corticoid (altim® 1.5 ml)

Treatment:

Drug: corticoid (altim® 1.5 ml)

physiological solution

Placebo Comparator group

Description:

Control arm: anesthetic bloc (1 ml of lidocaïne 1%) immediately followed with physiological solution (1.5 ml)

Treatment:

Drug: physiological solution (1.5 ml)